Needle guard

ABSTRACT

A needle guard assembly having a resilient arm extending from a base situated to slide along the shaft of a needle. In one implementation the needle guard has an elongate containment member that rides with the resilient arm and is co-operable with the resilient arm to effectuate a covering of the entire distal tip of the needle upon the needle being retracted into the needle guard.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/596,023, filed Aug. 27, 2012 which is a continuation-in-part of U.S.application Ser. No. 13/037,164, filed Feb. 28, 2011.

FIELD

The inventions disclosed herein relate to safety needle devices.

BACKGROUND

A number of U.S. Patents describe safety IV catheters where the distaltip of the needle is provided with a degree of protection after use,including but not limited to: McLees, U.S. Pat. No. 5,135,504; Erskine,U.S. Pat. No. 5,797,880; Woehr, et al., U.S. Pat. No. 6,287,278;Bialecki, et al., U.S. Pat. No. 6,652,486; McGurk, U.S. Pat. No.7,291,130; Rhad, et al., U.S. Pat. No. 7,303,548; Menzi, et al., U.S.Pat. No. 7,731,687; and Harding, et al., U.S. Pat. No. 7,828,774.

These prior art safety catheters all exhibit one or more drawbacks thatcould potentially place healthcare workers, or others at risk for apercutaneous or non-percutaneous blood or bodily fluids exposure afterthe needle tip is covered by the safety mechanism. Although the needletip itself is covered after use on a number of available safety IVcatheters, the entirety of the needle tip is not fully contained afteruse which could result in blood or fluid residing in the distal end ofthe needle lumen leaking, or otherwise escaping, into the workplace andcontacting a healthcare provider. For example, splattered blood couldenter a mucous membrane region of the eyes, nose or mouth of anyhealthcare personnel within close proximity to the splatter. Theexposure should then be reported and post exposure treatment,prophylaxis and follow up would occur, incurring costs to theinstitution and worry to the individual exposed to the blood.Additionally, some commercially available needle guards can be easilydefeated by an inadvertent incident where the components no longerprotect or shield the contaminated tip.

FIGS. 1-5 illustrate a safety needle guard 10 similar to the onedisclosed in U.S. Pat. No. 6,287,278. The needle guard 10 is constructedfrom a single piece of material as shown in FIG. 1 and formed to assumethe configurations depicted in FIGS. 2-5 during use. FIGS. 2 and 3 showdifferent side views of the needle guard 10 in a ready position wherethe distal tip 18 of the needle 15 is unprotected. FIGS. 4 and 5 showthe different side views of the needle guard 10 after the needle guardhas been activated to cover the distal tip 18. As shown in FIGS. 4 and5, although the extreme distal tip 18 of needle 15 is protected, theopen lumen 17 in the bevel region 16 of the needle remains exposed.Another problem associated with the needle guard 10 is that forces maybe applied to the needle guard arms 11 and 12 at locations to cause thedistal arm segments 13 and 14 to be urged outward. This creates a riskof having the distal arm segments 13 and/or 14 being moved away fromprotecting the distal tip 18.

SUMMARY

According to some implementations an intravenous (IV) catheter assemblyis provided comprising: a catheter hub comprising a hollow body having aproximal end and a distal end, the hollow body defining an interiorspace; a catheter having a proximal end and a distal end, the proximalend of the catheter coupled to the proximal end of the catheter hub; aneedle having a needle shaft and a distal tip, the needle moveablebetween a ready position and a retracted position, in the ready positionthe distal tip of the needle extending distally from the distal end ofthe catheter, in the retracted position the distal tip of the needleresiding in a position proximal to the proximal end of the catheter, theneedle shaft having a change in profile; and a needle guard comprisingan arm that extends distally from a base having an aperture formedtherein, the needle guard slideably mounted on the needle shaft with theneedle shaft passing through the aperture formed in the base, theaperture sized to engage with the change in profile of the needle shaftto limit the proximal movement of the needle with respect to the needleguard, the arm comprising a resilient material and having a proximalsection, a mid-section and a distal section, the distal section of thearm resides and is urged against a side of the needle shaft when theneedle is in the ready position, the needle guard further comprising anelongate member having a through passage extending between a proximalend and a distal end of the elongate member, the elongate memberextending distally from a position at or near the base and slideablealong the needle shaft as the needle is moved between the ready positionand the retracted position, the elongate member having a length suchthat substantially coincident with the change in profile engaging theaperture in the base the entirety of the distal tip of the needle ispositioned to reside within the through passage of the elongate memberand the distal section of the arm disengage with the needle shaft tomove radially inward to at least partially cover the distal end of theelongate member, the elongate member being sufficiently rigid torestrict longitudinal movement of the needle with respect to the needleguard when the distal section of the arm at least partially covers thedistal end of the elongate member.

According to other implementations an IV catheter assembly is providedcomprising: a catheter hub comprising a hollow body having a proximalend and a distal end, the hollow body defining an interior space; acatheter having a proximal end and a distal end, the proximal end of thecatheter coupled to the proximal end of the catheter hub; a needlehaving a needle shaft and a distal tip, the needle moveable between aready position and a retracted position, in the ready position thedistal tip of the needle extending distally from the distal end of thecatheter, in the retracted position the distal tip of the needleresiding in a position proximal to the proximal end of the catheter, theneedle shaft having a change in profile; and a needle guard comprisingfirst and second arms that extend distally from a base having anaperture formed therein, the needle guard slideably mounted on theneedle shaft with the needle shaft passing through the aperture formedin the base, the aperture sized to engage with the change in profile ofthe needle shaft to limit the proximal movement of the needle withrespect to the needle guard, each of the first and second armscomprising a resilient material and having a proximal section, amid-section and a distal section, the first and second arms extendingfrom different positions of the base and intersecting one another alongtheir mid-sections so that the distal sections of the first and secondarms reside and are urged against opposite sides of the needle shaftwhen the needle is in the ready position, the needle guard furthercomprising an elongate member having a through passage extending betweena proximal end and a distal end of the elongate member, the elongatemember extending distally from a position at or near the base andslideable along the needle shaft as the needle is moved between theready position and the retracted position, the elongate member having alength such that substantially coincident with the change in profileengaging the aperture in the base the entirety of the distal tip of theneedle is positioned to reside within the through passage of theelongate member and the distal section of at least one of the first andsecond arms disengages with the needle shaft and moves radially inwardto at least partially cover the distal end of the elongate member, theelongate member being sufficiently rigid to restrict longitudinalmovement of the needle with respect to the needle guard when the distalsection of at least one of the first and second arms at least partiallycovers the distal end of the elongate member.

According to some implementations the needle guard comprises a unitarystructure with the elongate member being integrally formed with the baseof the needle guard.

According to some implementations the needle is stopped in the retractedposition by component or feature incorporated with, or otherwisesituated, at or near the distal end of the elongate member.

According to some implementations a proximal section of the elongatemember comprises a reduced diameter portion and/or a frustoconicalportion useable to assist in self-centering the needle on the needleguard.

According to another implementation a safety needle device is providedcomprising: a needle having a needle shaft and a distal tip, the needleshaft having a change in profile near the distal tip; a needle guardtransitional between a ready state where the distal tip of the needle isin an unprotected state and an activated state where the distal tip ofthe needle is in a protected state, the needle guard comprising an armthat extends distally from a base having an aperture formed therein, theneedle guard slideably mounted on the needle shaft with the needle shaftpassing through the aperture formed in the base, the arm comprising aresilient material and having a proximal section, the needle guardfurther comprising an elongate member extending distally from a positionat or near the base and slideable along the needle shaft as the needleguard is moved between the ready position and the activated position,the elongate member having a proximal end, a distal end and a throughpassage extending therebetween, a first portion of the through passagelocated at or near the proximal end of the elongate member is sized toengage with the change in profile of the needle shaft to limit proximalmovement of the needle with respect to the needle guard, the elongatemember having a length such that when the change in profile engages thefirst portion of the through passage the entirety of the distal tip ofthe needle is positioned to reside within the through passage of theelongate member, the elongate member comprising a proximal section and adistal section, the proximal section of the elongate member disposedwithin the aperture of the base with the base being slideable on theproximal section of the elongate member between a first position whenthe needle guard is in the ready state and a second position distal tothe first position when the needle guard is in the activated state, whenthe needle guard is in the ready state the distal section of the armresides on the distal section of the elongate member near the distal endof the elongate member where at least a portion of the distal section ofthe arm is urged against an outer side of the elongate member, theneedle guard is configured such that as it transitions from the readystate to the activated state, upon a movement of the base from the firstposition to the second position, the distal section of the arm movesdistally along the outer side of the distal section to the distal end ofthe elongate member where it moves radially inward to at least partiallycover the distal end of the elongate member, the elongate member beingsufficiently rigid to restrict longitudinal movement of the needle withrespect to the needle guard when the distal section of the arm at leastpartially covers the distal end of the elongate member.

In other implementations needle guards are provided wherein biasingmembers act on the one or more arms of the needle guards to assist inurging the arms against the needle shaft or elongate member, as the casemay be, when the needle guards are in the ready state.

Many other implementations are disclosed and contemplated herein.Moreover, it is important to note that the inventions are not limited tosafety IV catheters, but are applicable to any of a variety of needleproducts including but not limited to syringes, guidewire introducers,blood collection devices, etc.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 through 5 illustrate a prior art needle guard;

FIGS. 6A through 6C illustrate implementations of a flat stock usable toform needle guards disclosed and contemplated herein;

FIGS. 7 through 10 illustrate a needle guard assembly according to oneimplementation;

FIGS. 11 through 17 illustrate protective elongate members according tovarious implementations;

FIGS. 18 and 19 illustrate a needle guard assembly according to anotherimplementation;

FIGS. 20 through 23 illustrate a needle guard assembly according toanother implementation;

FIG. 24 illustrates a needle guard assembly according to anotherimplementation;

FIGS. 25A-D illustrate needle guard elongate members according variousimplementations;

FIGS. 26 through 31 illustrate a needle guard assembly according toanother implementation;

FIGS. 32 through 34 illustrate a needle guard assembly according toanother implementation;

FIGS. 35 through 37 illustrate a needle guard assembly according toanother implementation;

FIG. 38 illustrates a safety intravenous catheter assembly according toone implementation;

FIGS. 39 and 40 illustrate a safety intravenous catheter assemblyaccording to another implementation;

FIG. 41 illustrates a needle guard assembly according to anotherimplementation;

FIGS. 42A-42D illustrate a safety intravenous catheter assemblyaccording to another implementation;

FIGS. 43A-43D illustrate a manner in which the needle guard of FIGS. 42may activate;

FIGS. 44A-44D illustrate a needle guard according to anotherimplementation in use within an intravenous catheter assembly;

FIGS. 45A-45D illustrate a needle guard according to anotherimplementation in use within an intravenous catheter assembly;

FIG. 46 shows an elongate member according to one implementation;

FIG. 47 shows an elongate member according to one implementation;

FIG. 48 shows an elongate member according to one implementation;

FIGS. 49A-49D illustrate a safety intravenous catheter assemblyaccording to another implementation;

FIG. 50 shows an elongate member according to one implementation;

FIG. 51 shows an elongate member according to one implementation;

FIG. 52 shows an elongate member according to one implementation;

FIG. 53 shows an elongate member according to one implementation;

FIG. 54 shows an elongate member according to one implementation;

FIG. 55A illustrates an elongate member according to one implementation;

FIG. 55B illustrated a base of a spring clip according to implementationwith a key hole provided for receiving the proximal end of the elongatemember of FIG. 55A;

FIG. 56A illustrates an elongate member according to one implementation;

FIG. 56B illustrated a base of a spring clip according to implementationwith a key hole provided for receiving the proximal end of the elongatemember of FIG. 56A;

FIGS. 57A and 57B illustrate the base of a spring clip according toother implementation;

FIGS. 58A-58C illustrate an elongate member having a seal membersituated at its distal end;

FIG. 59 illustrates a seal member according to another implementation;

FIGS. 60A-60C illustrate a needle guard assembly according to anotherimplementation incorporated within a guidewire introducer;

FIG. 61 illustrates a needle guard assembly according to anotherimplementation;

FIGS. 62A-62D illustrate a needle guard assembly according to anotherimplementation wherein spring means is integrally formed with the springclip;

FIGS. 63A-63D illustrate a needle guard according to anotherimplementation;

FIGS. 64A-64C illustrate a needle guard according to anotherimplementation;

FIG. 65 illustrates a needle guard according to another implementation;

FIGS. 66A-66C illustrate a needle guard according to anotherimplementation;

FIGS. 67A-67B illustrate a needle guard according to anotherimplementation;

FIGS. 68A-68B illustrate a needle guard according to anotherimplementation;

FIGS. 69A-69C illustrate a needle guard according to anotherimplementation;

FIGS. 70A-70B illustrate a needle guard according to anotherimplementation;

FIG. 71 illustrates a needle guard according to another implementation.

DETAILED DESCRIPTION

FIGS. 6 through 11 illustrate needle guards 100 according to someimplementation. According to one implementation, a first portion 110 ofthe needle guard 100 is manufactured from a flat material havingresilient characteristics, as shown in FIG. 6A or 6B, and shaped toassume the in-use configurations shown in FIGS. 7-10, whereas a secondportion 150 (see FIGS. 11 and 12) of the needle guard 100 defines anelongate member 152 having a through passage 153 extending between aproximal end 154 and an distal end 156. FIGS. 7 and 8 show differentside views of the needle guard 100 situated in a first axial position ona needle 130 with the distal end 134 of the needle being unprotected.FIGS. 9 and 10 show the different side views with the needle guard 100situated in a second axial position on the needle 130 with the distalend 134, including the entirety of the bevel 136, being protected.

In one implementation, the first portion 110 of the needle guard 100 hasfirst and second resilient arms 101 and 102, respectively, with each ofthe arms comprising a proximal section 103,104, a mid-section 105, 106and a distal section 107, 108. The first and second arms 101, 102 extenddistally from different positions of a base 118 and intersect oneanother along their mid-sections 105, 106 so that lip segments 111, 112of the distal sections 107, 108 reside at and are urged against oppositesides of the needle shaft 131 when the needle guard is situated in thefirst axial position. The first portion 110 of the needle guard 100 isslideably mounted on the needle shaft 131 with the needle shaft passingthrough an aperture 119 formed in the base 118. In one implementationthe aperture 119 is sized to engage with a change in profile 132 on theneedle to limit movement between the needle 130 and the needle guard 100in a first direction when the needle guard 100 is situated in the secondaxial position. The change in profile 132 may comprises a crimp on theneedle shaft 131 or any other form of enlargement such as those depictedin FIGS. 33 and 35.

As shown in FIG. 7, the elongate member 152 is situated in the needleguard 100 with its proximal end 154 positioned at or near the base 118,and with its distal end 156 positioned at or near lip segment 111 of arm101 when the needle guard is in the ready position. In someimplementations the elongate member 152 is substantially coaxial withthe needle 130 with the diameter or cross-sectional area of the throughpassage 153 being sufficiently large to permit the elongate member toslide over the change in profile 132. In other implementations theelongate member 152 is substantially coaxial with the needle 130 withthe diameter or cross-sectional area of all or a proximal portion of thethrough passage 153 being smaller than a cross-sectional area of thechange in profile 132. In implementations where all or a portion of thethrough passage 153 has a cross-sectional area smaller than across-sectional area of the change in profile 132, the through passage153 is made to be expandable over the change in profile 132, like, forexample that shown in FIG. 9. In some implementations the sections ofthe elongate member 152 where the through passage 153 has a smallercross-sectional area than the change in profile 132 are resilient tocause the cross-sectional area of the through passage 153 to contractinwardly after that portion of the through passage has crossed thechange in profile. In some implementations, as discussed in more detailbelow, only a proximal portion of the expandable member 152 has areduced cross-sectional area that is resiliently expandable over thechange in profile 132. In use, the elongate member 152 travels axiallyalong the shaft of the needle in conjunction with the first portion 110of the needle guard 100. In some implementations the elongate member 152rides with the first portion 110 of the needle guard with the proximalend 154 abutting the base 118. In other implementations the proximal end154 of the elongate member 152 is attached to base 118. In otherimplementations, a proximal portion or the entire elongate member 152 isintegral with the base 118.

FIGS. 9 and 10 show the needle guard 100 positioned on the needle 130 inthe second axial position with the needle tip 134, including theentirety of the bevel 136, being covered. In one implementation, as theneedle guard is advanced over the needle 130 and the lip segments 111and 112 are moved distal to the needle tip 134, the needle guard 100 isstopped in the second axial position by the engagement of the change inprofile 132 on the needle with the aperture 119 of base 118. Other stopimplementations are disclosed below. The length of the elongate member152 is selected so that substantially coincident with the change inprofile 132 engaging, for example, the aperture 119 in base 118 theentirety of the distal tip 134 and bevel region 136 of needle 130 ispositioned to reside within the through passage 153 and so that at leastone of the distal sections 107, 108 of arms 101, 102 disengage with theneedle to and advances to fully or at least partially cover the distalend 156 of the elongate member 152.

In one implementation, as shown in FIG. 7, the distal section 107 of arm101 is configured to assume a first angle with respect to the needleaxis when the needle guard 100 is positioned in a ready position and thedistal section 108 of arm 102 is configured to assume a second anglewith respect to the needle axis when the needle guard 100 is positionedin the ready position, the second angle being greater than the firstangle. Further, as shown in FIG. 9, when the needle guard 100 is in thesecond axial position the distal section 107 of arm 101 is oriented andbiased to assume a substantially perpendicular relationship with respectto the longitudinal axis of the elongate member 152. In someimplementations the cross-sectional area of the distal section 107 issufficient to cover the entirety of the distal end 156 of the elongatemember 152. In other implementations, less than the entirety of thedistal end 156 of the elongate member 152 is covered by distal section107.

As mentioned above, the distal end 107 of arm 101 may be biased so thatit applies a downward/proximally acting force on the distal end 156 ofelongate member 152 when the needle guard 100 assumes the second axialposition. In one implementation the bias is created by a resilient hingein the region 117. The application of a downward/proximally acting forceassists in the formation of a full or partial seal that may impede orprevent contaminants within the needle 130 and elongate member 152lumens from leaking out of the needle guard 100 after it has assumed thesecond axial position. In some implementations, the distal end 108 ofarm 102 is oriented and biased to assume an oblique angle with respectto the distal end 107 and to exert a force on the distal end 107 in adirection toward the distal end 156 of elongate member 152.

In implementations where the needle guard 100 forms a part of anintravenous catheter 700, as shown in FIG. 38, protrusions 117 and 116may be formed on arms 101 and 102, respectively, to engage with one ormore features 703 in the interior of the catheter hub 702 to releasablysecure the needle guard 100 in the catheter hub when the catheterassembly 700 is in a ready position.

As mentioned above, a problem associated with prior art spring clipneedle guard devices is that forces may be applied to parts of thespring clip arms to cause the distal arm sections to be urged outward.This creates a risk of the distal arm sections being moved away fromprotecting the needle tip after the needle guard has assumed a protectedposition. To address the problem, in some implementations the firstportion 110 of the needle guard 100 comprises straight, or substantiallystraight, arm segments 113 and 114 that are disposed proximal to distalarm sections 107 and 108, respectively. As shown in FIG. 9, the armsegments 113 and 114 are arranged so that when the needle guard 100assumes the second axial position on the needle 130, the arms segments113 and 114 abut and are laterally disposed on opposite sides of theouter surface of the elongate member 152. Arm segments 113 and 114 aredisposed to occupy positions between the distal sections 107, 108 andthe intersection point 126 of the arms 101 and 102 when the needle guardis in the second axial position. In one implementation arm segments 113and 114 are located adjacent to distal sections 107 and 108,respectively, and disposed a distance distal to the intersection point126 of the arms 101 and 102. In one implementation the distance(D₁)segment 113 is distally spaced from the intersection point 126 isgreater than or equal to L₁ sinβ, with L1 being the approximate distancebetween the intersection point 126 and the location arm 101 intersectsthe outer circumference of the elongate member 152 and β being the anglebetween arm 101 and a line running perpendicular to the longitudinalaxis of elongate member 152 at the intersection point 126. Although notrequired, segment 114 is preferably distally spaced from theintersection point 126 so to be substantially longitudinally alignedwith segment 113.

In some implementations segments 113 and 114 have substantially the samewidth as distal sections 107 and 108, respectively. In otherimplementations segments 113 and 114 have widths that are less thanthose of distal sections 107 and 108, respectively, as shown in FIG. 6B.In other implementations, one or both of segments 113 and 114 maycomprise arcuate portions that at least partially conform to portions ofthe outer curvature of the elongate member 152. An advantage of such aconfiguration is that the at least partial conformability of segments113, 114 with the outer surface of elongate member 152 acts to stabilizethe segments about the elongate member in the event improper forces areapplied to either or both of arms 101 and 102. In other words, the atleast partial conformability reduces the likelihood of arms 101 and/or102 slipping sideways on the outer surface of elongate member 152 whenimproper forces are applied to arms 101 and/or 102. As an example, andwith reference to FIG. 6A, the outer edges 121 and 122 of segments 113and 114 may be curved inward along cut-lines 123 and 124, respectively,to assume a partially curved configuration.

The first portion 110 and second portion 150 of the needle guard 100 mayassume any of a variety of configurations. Turning again to FIGS. 6A and6B, in one implementation the arm mid-sections 105 and 106 are narrowedsufficiently to accommodate the elongate member 152 with a clearanceexisting between the mid-sections 105 and 106 and the outer surface ofthe elongate member when the first portion 110 is formed into a springclip as exemplified in FIGS. 7-10. The dotted lines in FIGS. 6A and 6Bdepict folding locations for producing bends and/or hinges during thespring clip fabrication process.

In some implementations the elongate member 152 comprises one or morematerials having sufficient rigidity to resist buckling during use. Theone or more materials may comprise any of a variety or composition ofmaterials, such as for example, a metal, an elastomer/plastic, a braidedstructure, a random stranded structure, combinations thereof, etc.Elongate member 152 may comprise a plurality of portions or sectionsjoined together to form the elongate member.

Elongate member 152 may be fabricated, for example, utilizing adeep-draw fabrication process where a metal is work hardened during thedrawing process, thus eliminating the need for secondary heat-treatingon the finished part. Elongate member 152 may also comprise, forexample, an extruded portion of elastomer/plastic tubing.

According to some implementations, the through passage 153 in a proximalportion of the elongate member 152 adjacent or near the base 118 has areduced cross-sectional area/diameter that causes the proximal portionof the through passage 153 to engage with the change in profile 132 onthe needle shaft 131. In one implementation the reduced diameter portionof the through passage 153 acts as stop, in lieu of aperture 119 in base118, to limit movement of the needle guard 100 on the needle 130 to thesecond axial position. In other implementations a reduced diameterbushing or sleeve may be positioned at or coupled with the proximal end154 of the elongate member 152 to act as a stop.

According to other implementations, the proximal portion of the elongatemember 152 comprises a material that is capable of expanding or flexingover the change in profile 132 in a manner depicted in FIG. 9. In oneimplementation the proximal portion of the elongate member comprises aresilient material that permits it to expand over the change in profile132 while at the same time exerting a constraining/radial force on thechange in profile 132. An advantage of such implementations is that theradial constraining force applied to the change in profile 132 acts tolimit lateral movement of the elongate member 152 after the needle guard100 has been positioned to cover the distal end of the needle. This isparticularly advantageous when a full or partial seal between the distalsection 107 or arm 101 and the distal end 156 of elongate member 152 isdesired. According to other implementations the entirety of elongatemember 152 comprises a flexible material that allows the elongate memberto expand or flex over change in profile 132 of the needle 130 as theelongate member is slid or moved to the distal end of the needle.

FIG. 13 is a cross sectional side view of an implementation of elongatemember 152 having a reduced inner diameter proximal portion 155. Theelongate member 152 may also have an absorbent or porous innercoating/membrane/liner or the like 158 sized to contact the outerdiameter of needle 130 and absorb or wipe blood or bodily fluids fromthe exterior surface of the needle as the needle slides or moves throughthe elongate member. The absorbent or porous member 158 may also absorbblood or bodily fluids that reside in the needle lumen. In someimplementations the absorbent or porous member 158 includes amedication, such as, for example, an antimicrobial or antibiotic agent.

FIG. 14 is a cross sectional side view of an implementation of elongatemember 152 comprising a reduced diameter or frustoconical portion 159 atits proximal end 154 and a distal flange 157 at its distal end 156.According to one implementation the distal flange 157 provides a largercontacting surface 179 to facilitate the formation of a seal between thedistal section 107 of arm 101 and the distal end 156 of the elongatemember when the needle guard is positioned in the second axial positionon the needle 130. In other implementations the distal flange 157 andthe lip 111 of arm 101 are constructed so that upon the needle guard 100assuming the second axial position on the needle 130 the lip 111 engageswith the flange 157 to help secure the distal section 107 of arm 101 tothe distal end 156 of elongate member 152. In such implementations, thedistal flange 157 may be annular, continuous or segmented.

FIG. 15 is a cross sectional view of an implementation of elongatemember 152 comprising a proximal section having a reduced diameter orfrustoconical portion 160 transitioning to a reduced diameter endsection or sleeve 161. The elongate member 152 may also comprise adistal flange 157. In one implementation the proximal end section 161 isused for attaching the proximal end of the elongate member 152 to thebase 118. Attachment may be accomplished via stamping, pressing or othermechanical fastening processes. For example, the proximal section 161may be segmented to form tabs, or the like) that are fixed into aperture119 or other openings provided in the base 118. In other implementationsthe shape and size of the proximal section 161 permits it to be pressfitted into aperture 119. It is important to note that any of a varietyof other attachment methods, or combination of methods, may be used toattach the elongate members 152 disclosed and contemplated herein to thebase 118 of the needle guard. These methods may include the use ofadhesives, soldering, welding, mechanical attachment, etc. As will bediscussed in more detail below, in some implementations the elongatemember 152 is unitarily formed with the first portion 110 of the needleguard 100.

An advantage of providing areas/sections of reduced diameter along alength of the elongate member 152 is that these areas/sections assist inmaintaining the elongate member coaxially disposed on the needle 130which reduces friction or drag forces that may otherwise exist as theelongate member 152 is moved along the needle shaft 131. They alsoassist in urging or maintaining the elongate member 152 in a coaxialrelationship with the needle shaft 131.

FIG. 16 is an isometric view of an implementation of an elongate member152 having an enlarged diameter distal portion 164 and a small diameterproximal portion 163. FIG. 17 is a cross sectional view of oneimplementation of an elongate member according to FIG. 16 comprising aninner ring or bushing 165 retained within the cavity of the enlargeddiameter portion 164 that is situated to concentrically locate theneedle 130 within the elongate member 152 and to wipe blood or bodilyfluids from the exterior surface of the needle 130 as the needle slidesor axially moves through the elongate member 152. One advantage of theenlarged diameter distal portion 164 is that it provides a reservoir forcollecting blood or bodily fluids wiped from the exterior surface of theneedle and/or that emanate from the lumen of the needle. In oneimplementation the reservoir contains a coating or material forabsorbing the blood or bodily fluids. In one implementation theabsorbent material occupies all or a substantial portion of thereservoir and is deformable or pierceable to accommodate an introductionof the distal end of the needle into the reservoir region of theelongate member. In implementations where a seal is provided between thedistal end of the elongate member and the distal arm section 107, one ormore apertures may be provided in the wall of the reservoir to inhibitthe formation of a hydraulic lock. In one implementation the one or moreapertures in the wall of the reservoir are sufficiently small to preventor inhibit blood or bodily floods from passing there through.

In some implementations an internal or external sealing member isprovided at or near the proximal end 154 of the elongate member.

In other implementations the elongate member 152 comprises one or moreencapsulated annular rings, ribs or segments that deform or flex overthe change in profile 132 as the needle guard 100 is advanced over theneedle 130. In some implementations the elongate member 152 compriseselongate encapsulated portions that extend along all or a portion of thelength of the elongate member. In such implementations the encapsulationstructures may be formed by use of an extrusion process. Theencapsulated members may comprise chemical substances that are caused tointeract with one another as the one or more encapsulated members expandover the change in profile 132 and to solidify to lock the proximal end154 of the elongate member 152 onto the change in profile 132 of theneedle 130.

As discussed above, it may be desirable to form a partial or full sealat the intersection of the distal section 107 of arm 101 and the distalend 156 of the elongate member 152 when the needle guard 100 ispositioned in the second axial position. According to someimplementations, the inner surface of distal section 107 is coated orlaminated with a material, compound or agent conducive to forming a sealwith the distal end 156 of the elongate member 152 when the distalsection 107 comes into contact with distal end 156. Conversely, or inconjunction with coating or laminating the inner surface of distal armsection 107, the distal end 156 of elongate member 152 may also becoated or laminated with a material, compound or agent conducive toforming a seal. For example, in some implementations one or both ofdistal section 107 and distal end 156 comprise a formable material, suchas an elastomer, for effectuating a full or partial seal between themembers. Other examples include coating, laminating, or otherwisetreating one or both of the contact surfaces with a tacky substance oradhesive. Other examples may include the fixation of an elastomer O-ringon the distal end 156 of the elongate member 152 so that at least aportion of the O-ring extends distal to the end 156 so that it may matewith a contact surface of distal arm section 107. Other sealing methodsare also contemplated.

FIGS. 18 and 19 show a needle guard 200 according to anotherimplementation. The needle guard 200 is similar to that of needle guard100 described above except that arm 102 terminates at segment 114 whereit is attached to the outer surface of the elongate member 152. In oneimplementation, segment 114 is curved to produce an attachment surfacethat is the same as or approximates the curvature of the outer surfaceof the elongate member 152. In substantially all other respects theimplementations of the first portion 110 and the second portion 150 ofthe needle guard 200 function in the same way to effectuate a coveringof the distal end of the needle 130 as described above. It is importantto note that arm 102 may be fixed to the outer surface of the elongatemember 152 at more proximally located sites. For example, arm 102 maycomprise a shorter length with an end portion of the arm 102 beingattached anywhere along the length of the elongate member 152. In otherimplementations arm 102 is eliminated altogether with the distal end 154of the elongate member 152 being firmly coupled to the base 118.

According to other implementations the first portion 110 and theelongate member 152 of the needle guard 100 are unitarily constructed.In one implementation this accomplished by subjecting the base 118 ofthe needle guard to a deep drawing process to form the elongate member152. In this manner, the elongate member 152 may be described as beingco-extensive to the aperture 119 in the base 118. According to oneimplementation the unitary construction process begins with theformation of a metal strip 50 as shown in FIG. 6C having an area 52designated to form the base 118 of the needle guard 100. In someimplementations the metal strip 50 has a uniform thickness, while inothers the strip 50 is provided with an enhanced thickness dimension atleast in the region 54 where the deep drawing process is to be appliedto form the elongate member 152. In some implementation the arm sections101 and/or 102, as shown, for example in FIG. 6A, are formed prior todeep drawing the elongate member 152, while in other implementations thearm sections 101 and/or 102 are formed after the formation of theelongate member 152. In some implementations the fabrication processbegins with a metal sheet having a uniformed and enhanced thicknessdimension which is followed by a process that results in the flatteningof the metal sheet in the areas 56 and 58 where the arms 101 and/or 102are designated to reside. The flattening process may occur before orafter the formation of the elongate member 152 by use of the deepdrawing process. In conjunction with or after the flattening process toproduce one or more areas of a reduced thickness, at least a portion ofthe reduced thickness areas are cut to produce at least a portion ofarms 101 and/or 102.

With reference to FIGS. 13 through 17, one or more of the features 155,159, 160, 161, 163 and 164 may be formed into the elongate member 152during the deep drawing process by the use of one or multiple diesdimensioned and shaped to form the one or more features. For example, inone implementation the frustoconical portion 160 and reduced diameterend section 161 of the elongate member 152 is formed during the drawingprocess. An advantage of incorporating one or both of the features 160and 161 into the elongate member 152 is that they cause the proximalsection of elongate member 152 to be self-centered onto the needle 130during the assembly process.

According to another manufacturing process, a plurality of elongatemembers 152 are initially deep drawn, or at least partially deep drawn,from a single metal sheet prior to the metal sheet being segmented forthe purpose of forming the first portions 110 of the needle guard 100.

FIGS. 20 through 23 illustrate a needle guard assembly 300 according toanother implementation. The needle guard 300 is similar to that ofneedle guard 100 described above except that arm segments 113 and 114have been modified to include arcuate recesses 313 and 314 that areconfigured to at least partially coincide with the curvature of theouter surface of elongate member 152. In one implementation one or bothof the recesses 313 and 314 are configured as half-circles that areshaped to coincide with the outer profile of the elongate member 152when the needle guard 300 is in the second axial position to protect thedistal end of needle 130. The circumferential edges of recesses 313 and314 rest against the outer surface of the elongate member 152 when theneedle guard 300 is in the second axial position (FIG. 23) to inhibitthe distal sections 107 and 108 of arms 101 and 102 from being urgedoutward away from covering the distal end of the needle 130 in the eventan improper force is applied to one or both of the arms.

As shown in FIG. 21, a method of fabricating a needle guard according tothe implementations disclosed and contemplated herein is to first stamp,cut or otherwise form the first portion 310 of the needle guard from aflat piece of resilient material as exemplified in FIG. 20. After thefirst portion 310 is formed the elongate member 152 may be positioned sothat the through passage 153 is axially aligned with the aperture 119 inbase 118. A fixture extending through the aperture 119 and through atleast a portion of the through passage 153 may be used to support theelongate member 152. According to other methods, the proximal end 154 ofthe elongate member 152 is provided with an outer reduced diametersegment 169 that extends through or is otherwise fitted to aperture 119to fully or partially support the elongate member 152 in a perpendicularrelationship with the first portion 310 as shown in FIG. 21. In oneimplementation, a reduced diameter annular ring located near theproximal end 154 of the elongate member 152 provides a means to snap fitthe proximal end of the elongate member into the base aperture 119 tosecure the elongate member 152 to the base 118. In otherimplementations, a slit or slot is provided in the base 118 that extendsfrom a side edge of the base to the aperture 119. In this manner theelongate member 152 may be provided with a reduced diameter annular ringportion near its proximal end 154 that permits the elongate member to beside loaded and fixed within the aperture 119 to effectuate anattachment of the elongate member 152 to the base 118. Upon the elongatemember 152 being properly supported on or attached to the first portion310, the first portion may be bent or partially bent to produce orpartially produce the requisite arm portions and hinges. At this stagethe first portion 310 and elongate member 152 may be loaded onto theneedle 130 with the first portion 310 being further bent (if required)and arranged on the needle 130 in a manner depicted in FIG. 22.

According to some implementations the first portion 310 and elongatemember 152 of needle guard 300 are unitarily constructed.

FIG. 24 shows a needle guard 350 according to another implementation.The needle guard 350 is similar to that of needle guard 300 describedabove except that arm 102 terminates just distal to recess 314 alongdotted line 320. In such an implementation the recess portion 314 iscontinually urged into contact with the outer surface of the elongatemember 152 with the distal section 107 of arm 101 situated to singularlycover the distal end 156 of the elongate member when the needle guard350 is situated in the second axial position on the needle 130. The arms101 and 102 of needle guards disclosed and contemplated herein maycomprise different types of features as exemplified in FIG. 24 where arm102 is comprises a recess 314 for abutting the outer surface of elongatemember 152 and where arm 101 comprises an elongate surface 113 forabutting the outer surface of the elongate member 152.

According to some implementations the first portion and elongate memberof the needle guard of FIG. 24 is unitarily constructed.

According to some implementations, as shown in FIGS. 25A, the elongatemember 152 comprises a resilient structure 170 having over-lappinglongitudinal portions 171 and 172 that are separable to form a temporarylongitudinal slit or slot along the length of the elongate member topermit it to be side-loaded onto the needle 130. FIG. 25A represents atop view of the elongate member 152. Upon the elongate member 152 beingside-loaded onto the needle shaft, the resilient structure 170 resumes,or substantially resumes, its initial configuration to completelysurround the circumference of the needle shaft 131. In oneimplementation the resilient structure 170 comprises an elastomermaterial having surface characteristics that facilitate the formation ofa seal along the over-lapping longitudinal portions 171 and 172 whentheir contact surfaces are brought into contact with one another. Inother implementations the resilient structure 170 comprises a metal. Insome implementations one or both of the over-lapping contact surfaces ofportions 171 and 172 is treated or otherwise coated with a substance toinduce the formation of a seal along the length of the elongate member152. In other implementations a seal is formed between the overlappingportions 171 and 172 by use of a sonic welding process or the like.

In other implementations, as illustrated in FIGS. 25B-D, the elongatemember 152 comprises one or more slits 175 a, 175 b that are separableto facilitate a side loading of the elongate member onto the shaft of aneedle. As with some of the implementations of FIG. 25A, the elongatemember 152 may comprise an elastomer material having characteristicsthat facilitate the formation of a seal between the mating surfaces ofthe slits when their contact surfaces are brought into contact with oneanother. In other implementations one or both of the contact surfaces ofslits is treated or otherwise coated with a substance to induce theformation of a seal along the length of the elongate member 152. Inother implementations a seal is formed between mating surfaces of theslits by use of a sonic welding process or the like.

FIGS. 26 through 31 illustrate a needle guard assembly 400 according toanother implementation. The needle guard 400 is similar to that ofneedle guard 100 described above except that arm segments 113 and 114have been modified to include formed portions 413 and 414 that areconfigured to at least partially coincide with the curvature of theouter surface of elongate member 152. A proximal section of the elongatemember 152 also includes a frustoconical portion 160 and a reduceddiameter portion 161 like that depicted in FIG. 15. In oneimplementation one or both of the proximal edges 415, 416 of formedportions 413, 414 are shaped to coincide with the outer profile of theelongate member 152 when the needle guard 400 is in the second axialposition to protect the distal end of needle 130. In practice the innersurfaces of the formed portions 413 and 414 rest against the outersurface of the elongate member 152 when the needle guard 400 is in thesecond axial position to inhibit the distal sections 107 and 108 of arms101 and 102 from being urged outward away from covering the distal endof the needle 130 in the event an improper force is applied to one orboth of the arms 101, 102 as illustrated in FIG. 29. FIG. 30 is anisometric view of the needle guard assembly 400 situated on the needle130 in the first axial position. FIG. 31 is an isometric view of theneedle guard assembly 400 situated on the needle 130 in the second axialposition.

According to some implementations, the first portion 410 and elongatemember 152 of needle guard 400 are unitarily constructed.

Like the implementation described above in conjunction with FIG. 24, itis appreciated that the needle guard 400 may be modified so that arm 102terminates at a location just distal to formed portion 414. In such animplementation the formed portion 414 is continually urged into contactwith the outer surface of the elongate member 152 with the distalsection 107 of arm 101 situated to singularly cover the distal end 156of the elongate member when the needle guard is situated in the secondaxial position on the needle 130.

FIG. 61 represents a needle guard assembly similar to that shown in FIG.30, with there being several distinguishing features. A firstdistinguishing feature lies in the construction of the needle. In theassembly of FIG. 30 a discrete change in profile 132 is provided as alimiting means at a distal end section of the needle near its distal tip134, whereas in the assembly of FIG. 61 the limiting means comprisesproximal shoulder 402 of a diametrically enlarged elongate section 401at the distal end of the needle. Another distinguishing feature lies inthe construction of the elongate member. In the implementation of FIG.30, the proximal section of the elongate member 152 includes a reduceddiameter portion 161 that is configured to act upon the change inprofile 132 on the needle to stop the needle guard on the needle when ithas been activated to cover the needle's distal tip 134. In theimplementation of FIG. 61 the elongate member 408 comprises adiametrically uniform construction with a tongue 409 cut into a proximalend section of the elongate member. Once formed, the tongue 409 iscrimped or bent inward so that at least a portion of the tongue resideswithin the elongate member 408. The portion of the tongue 409 residingwithin the elongate member is configured to engage with the shoulder 402on the needle to stop the needle guard on the needle when it has beenactivated to cover the needle's distal tip 403. In some implementationstwo or more tongues are provided.

It is important to note that many of the number of needle guard featuresdisclosed herein (both above and below) are interchangeable among thenumerous implementations disclosed and contemplated herein. For example,although some implementations disclose the use of features 113, 114 andother features 313, 314 and others 413, 414, it is appreciated that acombination of these features may be incorporated into a needle guardaccording to the inventions disclosed herein. Further, as an example,the variety of elongate members 152 and elongate features disclosedherein are interchangeable among the numerous implementations disclosedand contemplated herein.

FIGS. 32 through 34 illustrate a needle guard assembly 500 similar tothe needle guard assembly 300 described above except that the distal end502 of the elongate member 152 comprises an oblique orientation withrespect to the longitudinal axis of the elongate member and the distalsection 107 of arm 101 is angularly oriented to assume the obliqueorientation of the distal end 502 of the elongate member when the needleguard assembly 500 is in the second axial position as shown in FIG. 34.A proximal section of the elongate member 152 also includes afrustoconical portion 160 and a reduced diameter portion 161 like thatdepicted in FIG. 15. Distal section 107 is preferably configured toexert a force on the distal end 502 of the elongate member 152 when theneedle guard is in the second axial position. The lip 504 located at thedistal end of section 107 is also oriented in a downward facing positionand is situated to traverse the beveled distal opening of the elongatemember 152 to provide a mechanical stop that inhibits the distal armsection 107 from separating from the distal end 502 of the elongatemember when a compressive force or “pinch” is applied to one or both ofarms 101 and 102.

According to some implementations the first portion and elongate member152 of needle guard 500 are unitarily constructed.

A downward facing lip may be provided at the distal end of the distalsections 107 in the various implementations disclosed herein to inhibitthe distal arm section 107 from separating from the distal end of theelongate member 152 when a compressive force or “pinch” is applied toone or both of arms 101 and 102. In some implementations the distal endof the elongate member 152 is provided with an indentation or kerf tointerlock with a lip provided at a distal end of section 107.

FIGS. 35 through 37 illustrate a needle guard 600 according to anotherimplementation. The needle guard comprises a first portion 610 with anelongate member 652 integrated therein. In one implementation the firstportion 610 includes first and second arms 601 and 602, respectively,that extend from opposite sides of a base 618. The first portion ispreferably fabricated from a single piece of resilient material that isbent to form the base 618, arms 601, 602 and distal arm sections 607,608. An aperture in the base 618 (not shown) is sized to receive aproximal portion 136 of the needle 130 and to guide the needle guardalong the needle shaft as it transitions from a first axial position (asshown in FIGS. 35 and 36) to a second axial position to protect thedistal end 134 of the needle (as shown in FIG. 37). The arms 601, 602are hinged at the base 618 and are configured to assume an abuttingrelationship with the outer surface of the needle 130 when the needleguard 600 is situated in a first axial position with the distal end 134of the needle is unprotected. An elongate member 652 having proximal anddistal ends 654 and 656, respectively, is provided with an internalthrough passage 653 that extends between the two ends. The needle 130comprises a proximal shaft portion 136 and a flared distal shaft portion138 of increasing diameter. In use, the elongate member 652 is situatedto reside in the first portion 610 between the base 618 and the distalarm section 608. In one implementation the aperture in base 618 is sizedto engage with flared distal shaft portion 118 to stop the needle guard600 in the second axial position as depicted in FIG. 37 with theentirety of the internal passage 653 of the elongate member 652 having adiameter sufficient to be advanced so that the distal end 656 of theelongate member extends to or past the distal tip of the needle. Inanother implementation the proximal end of the elongate member 652 isprovided with a reduced internal diameter portion that acts to stop theneedle guard in the second axial position. In another implementation asleeve or bushing is situated at the proximal end 654 of the elongatemember 652 and includes an internal bore with diameter sufficient to actas the second axial position stop.

As illustrated in FIG. 37, substantially coincident with the distal end656 of the elongate member 652 situated to cover the entirety of thedistal end 134 of the needle 130, arms 601 and 602 disengage from theneedle shaft and are urged inward by stored energy to cover the distalend of the elongate member. According to one implementation, distal armsection 608 is hinged at location 620 to provide a downward/proximallyacting force on the distal end 656 of elongate member 652. In oneimplementation arms 601 and 602 are provided with protrusions 619 and620 that function to interact with one or more internal features of acatheter hub to releasably secure the needle guard 600 within thecatheter hub in a manner similarly described with respect to FIG. 38.

According to some implementations the first portion and elongate member652 of needle guard 600 are unitarily constructed.

As discussed above, FIG. 38 is a side view of a safety intravenouscatheter assembly 700 in a ready to use operative position according toone implementation. Assembly 700 includes a needle 130 with a sharpeneddistal tip 134 with an internal lumen extending from a proximal end 140to the tip 134. A change in profile 132 on the needle shaft functions tostop the needle guard 100 in the second axial position as previouslydescribed. A proximal end portion of the needle 130 is attached to aneedle hub 704 having proximal protrusions 706 for attaching a male luerfitting. The proximal end 140 of the needle being situated in aflashback chamber 708 of the needle hub 704. As previously discussed,the needle guard 100 is releasably secured in the catheter hub 702 bythe engagement of protrusions 117 and 116 with a feature or features 703situated on the inner wall of the catheter hub. The proximal end of thecatheter hub 702 is operatively engaged with the distal end of theneedle hub 704. A tubular catheter 710 extends distally from the distalend of the catheter hub 702 in coaxial relationship with needle 130 andterminates proximal to the needle tip 134 so that the needle tip isexposed for puncturing a blood vessel and introducing the catheter 710.In use, upon the catheter 710 being properly introduced into the vesselof a patient, the needle hub 704 is pulled proximally to retract theneedle tip 134 from the patient and into the needle tip guard 100. Asthe needle is withdrawn, the needle guard 100 is secured within theneedle hub 702 by the outward force exerted by protrusions 117 and 116.The location of the change in profile 132 on the needle 130 incombination with the dimensional characteristics of the needle guard 100result in the distal tip 134 being fully housed within the elongatemember 152 substantially coincident with the change in profile 132 beingstopped on the needle guard. Upon the distal tip 134 entering the distalend 156 of the elongate member 152, the distal arm segments 107 and 108disengage the needle shaft and are urged inward to cover the distal end156 of the elongate member by stored energy in the arms 101 and 102. Atthe same time protrusions 116 and 117 disengage with the catheter hub702 to permit the needle guard 100 and needle 130 to be fully removedfrom the catheter hub 702.

FIGS. 39 and 40 illustrate an intravenous catheter assembly 800according to another implementation. Assembly 800 is similar to that ofassembly 700 discussed above. A difference lies in the manner in whichthe needle guard 100 is releasably secured within the catheter hub 802.In the assembly 800, in lieu of the use of protrusion 117, 118 formed onarms 101, 102, resilient tabs 810 and 811 situated at or near the baseof the needle guard 100 protrude outward to engage one or more features803 of the inner wall of the catheter hub 802. The outer engagingsurfaces of tabs 810 and 811 are preferably arcuate to coincide with thecurvature of the inner wall of the catheter hub 802. The one or morefeatures 803 may comprise a recess, undercut, void, groove, protrudingfeature, etc., configured either annularly or in segments about theinner wall. The resilient tabs 810 and 811 are configured to exert anoutward force to cause the engaging surfaces to engage with the one ormore features 803 when the assembly 800 is in the ready position orduring the withdrawal of the needle 130 into the needle guard 100. Theengagement force of tabs 810 and 811 is sufficiently low to permit thetabs to disengage from the one or more features 803 (see FIG. 40) when aproximal force is applied to the needle guard upon the change in profile132 of the needle engaging needle guard stop.

FIG. 41 illustrates a needle guard assembly 900 situated in a protectiveposition on a Huber needle, the Huber needle being characterized by achange in axis or bend near the distal end of the needle 190. The needleguard assembly 900 is in many respects similar to some of theimplementations disclosed and described above except that the internalpassage extending through the elongate member 952 is configured in sucha way that permits the distal portion 958 of the elongate member tomaneuver around the change in axis and to cant as the needle 190 isretracted into a protected position within the elongate member 952. Inone implementation a proximal end section 960 of the elongate member 952is provided with a reduced inner diameter segment of an appropriatelength that stops the needle guard on the change in axis. In otherimplementations, a sleeve of sufficient length with a reduced innerdiameter is attached to or otherwise coupled to the proximal end ofelongate member 952. In other implementations a change in profile orenlargement is situated proximal to the change in axis to act as thestop.

FIGS. 42A-42D illustrate an intravenous catheter assembly 210 accordingto other implementations. The intravenous catheter assembly 210 differsfrom the intravenous catheter assembly 700 of FIG. 38 in that the distalsections 107, 108 of resilient arms 101, 102 are not biased against theneedle shaft 131 when the needle guard 100 is in the ready position, butare instead biased against the elongate member 212 as shown in FIG. 42A.As shown in FIG. 42D, in one implementation elongate member 212comprises a distal section 214 and a reduced diameter proximal section216. The outer diameter of the proximal section 216 is sufficientlysmall to reside within the aperture 119 in the base 118 with the outerdiameter of at least a portion of the distal section 214 nearest theproximal section 216 having a diameter that is greater than aperture119. The outer diameter of at least a portion of the proximal section216 is sufficient to permit the base 118 of the spring clip 220 to slideaxially along a length of the proximal section 216 as will be describedin more detail below.

As shown in FIGS. 42A and 42B, in the ready position, the base 118 ofthe spring clip 220 resides on the reduced diameter proximal section 216of elongate member 212 at a location proximal to the distal section 214,with a distance D1 being provided to permit the base 118 to travelaxially along the reduced diameter proximal section 216. In oneimplementation, when in the ready position, the axial position of thespring clip 220 on the elongate member 212 is releasably fixed by theengagement of the lip segments 111, 112 within one or more recesses 217,218 located near the distal end of the elongate member 212. In otherimplementations other co-operable features are provided near the distalend of the elongate member 212 for engaging the lip segments 111 and 112to assist in delimiting the axial and angular position of the springclip 220 on the elongate member 212 when in the ready position. In someimplementations the recesses 217, 218 impede or limit the spring clip'sability to rotate on the elongate member 212 so as to maintain thedistal sections 106, 107 of resilient arms 101, 102 properly orientedwith the distal end of the elongate member. In some implementations onlya single recess (or other single limiting feature) is provided near thedistal end of the elongate member 212 to delimit the spring clip'sposition on the elongate member.

In some implementation, as shown in FIG. 52, the cooperating feature onthe elongate member comprises an annular ring 213 with a proximalshoulder 222 on which the upper portions of the lip segments 111, 112rest. In one implementation the plane intersected by the annular ring213 is oblique to the longitudinal axis of the elongate member, as shownin FIG. 52. In other implementations, the elongate member comprises adistal end 223 that is substantially orthogonal to the longitudinal axisof the elongate member. In such an implementation the plane intersectedby the annular ring 224 may also be arranged orthogonal to thelongitudinal axis of the elongate member as shown in FIG. 53. In each ofthe implementations of FIGS. 52 and 53, the annular rings may besubstituted with discrete first and second raised sections that areangularly and longitudinally situated on the surface of the elongatemember to respectively engage lips 111 and 112. In other implementationsnot shown in the figures, raised features on the surface of the elongatemember form pockets for receiving the lip segments 111, 112 to impedeaxial and rotational movement of the spring clip 220 on the elongatemember when the spring clip is in the ready position.

As previously discussed, the spring clip 220 is releasable secured inthe catheter hub 702 by the engagement of protrusions 116 and 117 with afeature or features 703 situated on the inner wall of the catheter hub702. The proximal end of the catheter hub 702 is operatively engagedwith the distal end of the needle hub 704. A tubular catheter 710extends distally from the distal end of the catheter hub 702 in coaxialrelationship with needle 130 and terminates proximal to the needle tip134 so that the needle tip is exposed for puncturing a blood vessel andintroducing the catheter 710. In use, upon the catheter 710 beingproperly introduced into the vessel of a patient, the needle hub 704 ispulled proximally to retract the needle tip 134 from the patient andinto the needle guard. As the needle is withdrawn, the needle guard issecured within the catheter hub 702 by the outward force exerted byprotrusions 116 and 117, while at the same time the spring clip 220 isheld axially on the elongate member 212 by an inward force exerted bylip segments 111 and 112 within recesses 217 and 218, respectively. Whenthe change in profile 132 of needle 130 is stopped within the elongatemember 212, a continued proximal pull on the needle hub 704 causes thebase 118 of the spring clip 220 to advance distally on the reduceddiameter proximal section 216 of elongate member 212 until the base 118rests against a shoulder/ledge 219, or the like, located at a proximalend of the distal section 214 of elongate member 212. (In otherimplementations, as shown in FIG. 54, a stop 219 a in the form of anannular ring extends radially from the exterior surface of the distalsection 214 of the elongate member 212 to limit the axial advancement ofthe base 118 of the spring clip 220 on the elongate member 212.) At thesame time, the force M applied by the proximal pull is sufficient tocause the lip segments 111 and 112 to slip out of their respectiverecesses 217 and 218 and advance distally so that the distal armsegments 107 and 108 of spring clip arms 101 and 102 advance over thedistal end 221 of the elongate member 212. In one implementation, thefull distal advancement of the base 118 on the proximal section 216 ofelongate member 212 occurs substantially coincident with the distal tip134 of the needle 130 entering the distal end 221 of the elongate member212. At the same time, protrusions 116 and 117 disengage with thecatheter hub 702 to permit the needle guard to be fully removed from thecatheter hub 702. FIG. 42C shows the assembly with the distal tip 134 ofneedle 130 safely secured within the elongate member 212 of the needleguard.

In one implementation, as illustrated in FIGS. 43A-43D, the spring clip220 is adapted to elongate upon a proximal force M being applied to theneedle hub 704 when the change in profile 132 of needle 130 is stoppedwithin the elongate member 212. Initiation of the elongation may occurat a point in time when the base 118 of spring clip 220 engages theshoulder/ledge 219 of the elongate member 212, or before. As shown inFIG. 43B, the elongation occurs as a result of the resistance betweenthe protrusions 116 and 117 of the spring clip 220 with the features orfeature 703 situated on the inner wall of the catheter hub 702. Theinitial elongation is denoted in FIG. 43B by the annotation L1. In theimplementation of FIGS. 43, when the base of 118 of the spring clip 220engages shoulder/ledge 219, the axial advancement of the spring clip onthe reduced diameter proximal section 216 of the elongate member 212 isinsufficient by itself to cause the lip segments 111 and 112 to advanceover the distal end 221 of the elongate member. It is instead acombination of the axial advancement of the base 118 on the proximal endof the elongate member 212 and the elongation of the spring clip 220(denoted by the annotation L2 in FIG. 43C) that cause the lip segments111, 112 to advance over the distal end 221 of the elongate member. Uponthe spring clip 220 being activated to cover the distal end 221 of theelongate member 212, by virtue of the elongation of the spring clipduring the activation process, the distal end segment 117 of resilientarm 101 will exert an additional downward force on the distal end 221 ofthe elongate member as it resiliently attempts to assume a lengthshorter than L2. Such closure provides enhanced containment of thedistal end 134 of needle 130 within elongate member 212.

In another implementation, as shown in FIGS. 44A-44D, the elongatemember 230 is provided with no reduced diameter proximal section 216.Instead, in the ready position the base 118 of the spring clip 220 restsagainst the inside surface of base 118 or is secured at or near theproximal end of the elongate member 230. According to thisimplementation, the dimensional and material characteristics of thespring clip 220 along with the applied forces between the protrusions116 and 117 and the wall features 703 of the catheter hub 702 areselected so that an elongation of the spring clip 220 by itself resultsin an advancement of the lip segments 111, 112 over the distal end 234of the elongate member 230 to contain the needle tip 134 securely withinthe elongate member. FIGS. 44A-44D show the base 118 of the needle clip220 attached to the elongate member 230 with a proximal portion 232 ofthe elongate member extending through the aperture 119 of the base.FIGS. 45A-45D show an alternative implementation wherein the elongatemember 230 (of a shorter length) is positioned entirely distal to thebase 118. In such implementations the end 236 of the elongate member 230may be attached to the base 118 or may simply rest against it.

In implementations where the base 118 of the spring clip 220 moves alonga proximal section of the elongate member to effectuate an actuation ofthe needle guard assembly, such as those described above in conjunctionwith FIGS. 42 and 43, alternative elongate member constructions arecontemplated. For example, in the implementations of FIG. 42 the axialposition of the spring clip 220 on the elongate member 212 is held inthe ready position by an interaction between lip segments 111, 112 ofthe spring clip with recesses 217, 218 located near the distal end ofthe elongate member. In other implementations the spring clip 220 isentirely, or at least partially, held in the ready position by aninteraction of the base 118 of the spring clip with a proximal sectionof the elongate member 212. In implementations where the spring clip 220is entirely held in the ready position by an interaction of the base 118with a proximal section of the elongate member, the use of recesses 217,218, or other retaining features, on the distal section 214 of theelongate member are not necessary.

FIG. 46 illustrates an implementation wherein one or more raisedportions 238 are circumferentially disposed about the reduced diameterproximal section 216 of elongate member 212. The one or more raisedportions 238 are dimensioned to interact with the aperture 119 in thebase 118 of the spring clip 220 to inhibit distal axial advancement ofthe base 118 on the proximal section 216 until a sufficient force isapplied to overcome a resistance between the circumferential region ofaperture 119 and the one or more raised portions 238. In someimplementation the portion of the base 118 that circumscribes theaperture 119 is deformable upon the application of a force being appliedthereto by the one or more raised portions 238 to facilitate anadvancement of the aperture 119 over the one or more raised portions 238when the elongate member is proximally pulled upon. In someimplementations the one or more discrete raised portion 238 issubstituted with a raised annular ring.

In other implementations the spring clip 220 is at least partially heldon the elongate member in the ready position by use of an annular recess254 situated on a proximal section of the elongate member. FIG. 47illustrates an elongate member 250 having a distal section 251 and areduced diameter proximal section 252. The reduced diameter proximalsection 252 has a diameter that is generally greater than the diameterof the aperture 119 in the base 118 of spring clip 220. Situated withinthe reduced diameter proximal section 252 is an annular recess 254 thatis dimensioned to receive a portion of the base 118 of spring clip 220that circumscribes aperture 119. A portion of the base 118 that fully orpartially circumscribes the aperture 119 is sufficiently resilient topermit the diameter of the aperture 119 to expand when the spring clip220 is initially loaded onto the proximal section 252 of the elongatemember 250. The portion of the base 118 that circumscribes the aperture119 is also sufficiently resilient to permit the diameter of theaperture 119 to expand and to be moved out of the annular recess 254 andto be distally advanced along the reduced diameter proximal section 252of the elongate member 250 upon a sufficient force being applied to thebase 118. An advantage of this construction is that when the spring clip220 is activated to cover the distal end 255 of the elongate member 250,the compression fit between the base 118 of the spring clip 220 and theproximal section 252 inhibits or minimizes axial and radial movement ofthe spring clip 220 on the elongate member 250.

FIG. 48 illustrates an elongate member 260 similar to the elongatemember 250 of FIG. 47 in that it possesses an annular recess 264 forreceiving a portion of the base 118 that circumscribes the aperture 119.The difference elongate member 260 and elongate member 250 is thatelongate member 260 has a generally uniform cross-sectional along itslength.

FIG. 49A illustrates an elongate member 270 according to anotherimplementation. The elongate member 270 has a distal section 271 and aproximal section 272. The proximal section 272 comprises a reduceddiameter proximal segment 273 and a frustoconical segment 274 whosediameter transitions from the reduced diameter dimension at its proximalend 275 to a larger diameter at its distal end 276. In oneimplementation the diameter at the distal end 276 is at least equal tothe diameter of the distal section 271 of the elongate member 270. Asshown in FIG. 49B, in one implementation the spring clip 220 isassembled onto the elongate member 270 so that the reduced diameterproximal segment 273 extends through the aperture 119 in base 118. Insome implementations the aperture 119 has a diameter that is justslightly larger than the outer diameter of the proximal segment 273. Inother implementations the diameter of the aperture 119 and the outerdiameter of the proximal segment 273 are selected to produce africtional fit between the periphery of the aperture 119 and the outersurface of the proximal segment 273 with the frictional fit permitting asliding relationship between the two parts. In other implementations thediameter of the aperture 119 prior to the spring clip 220 beingassembled with the elongate member 270 has a diameter less than theouter diameter of the proximal segment 273. In a manner similar to thatdiscussed above, in such implementations at least a portion of the base118 that fully or partially circumscribes that aperture 119 isdeformable (plastically and/or elastically) to permit the diameter ofthe aperture 119 to conform to the outer diameter of the proximalsegment 273. The material and dimensional characteristics of the base118 and the proximal segment 273 permitting a sliding relationshipbetween the two parts upon a minimum axial force being applied thereto.

In one implementation, in the ready position the base 118 of the springclip 220 resides at the proximal end 275 of frustoconical segment 274,while in other implementations the base 118 resides on the proximalsegment 273 as shown in FIG. 49C. In use, upon the catheter 710 beingproperly introduced into the vessel of a patient, the needle hub 704 ispulled proximally to retract the needle tip 134 from the patient andinto the needle guard. As the needle is withdrawn, the needle guard issecured within the catheter hub 702 by the outward force exerted byprotrusions 116 and 117, while at the same time the spring clip 220 isheld axially on the elongate member 270 by an interaction of the base118 with the proximal section 272 of the elongate member 270 asdescribed above. When the change in profile 132 of needle 130 is stoppedwithin the elongate member 270, a continued proximal force M applied tothe needle hub 704 causes the base 118 of the spring clip 220 to advancedistally onto frustoconical segment 274 by virtue of the deformablecharacteristic of at least a portion of the base 118 as described above.In one implementation distal advancement of the base 118 proceeds untilit reaches the distal end 276 of the frustoconical segment 274 or aproximal end of distal section 271. Just prior to, or coincident withthe base reaching its distal-most position on the proximal section 272of the elongate member 270, the distal tip 134 of needle 130 fullyenters the elongate member 270 and the lip segments 111 and 112 of thespring clip 220 advance over the distal end 278 of the elongate memberas shown in FIG. 49D to safely secure the tip 134 within the elongatemember. An advantage of this construction is that when the spring clip220 is activated to cover the distal end 278 of the elongate member 270,the compression fit between the base 118 of the spring clip 220 and thedistal end 276 of the frustoconical segment 274 inhibits or minimizesaxial and radial movement of the spring clip 220 on the elongate member270.

FIG. 50 illustrates an elongate member 280 having a similar constructionto that of elongate member 270. A difference is the inclusion of a stop284 positioned at or near the proximal end of distal section 271. Thestop 284 may be in the form of an annular ring as shown in FIG. 50, ormay comprise one or more raised segments disposed about the periphery ofthe elongate member 280. The diameter of the stop 284 is sufficientlylarge to positively prevent advancement of the spring clip base 118beyond the stop.

FIG. 51 illustrates an elongate member 290 similar to elongate member270 except that the entirety of the proximal distal section 272comprises a frustoconical configuration.

According to some implementations the proximal section of the elongatemember is equipped with one or more elongate radially extendingprotrusions 295 as shown in FIG. 55A (only on protrusion shown in FIG.55A). In such implementations the aperture 119 in the base 118 of springclip 220 has a corresponding indentation or notch 296 for receiving theone or more radial protrusions 295 as shown in FIG. 55B. A host ofconfigurations are possible. Keying the proximal section of the elongatemember to the aperture 119 in the base 118 of the spring clip 220provides several advantages. First, during operation it inhibits arotation of the spring clip 220 on the elongate member as it is axiallyadvanced thereon. Second, during the manufacturing/assembly process itmakes it easier to properly orient the spring clip on the elongatemember. Third, it can prevent an improper pairing of spring clips andelongate members during the assembly process. According to oneimplementation, length of the one or more radial protrusions 295 isselected so that the spring clip 220 is prevented from rotating on theelongate member at all times. That is, when the needle guard is in theready state and the activated state. In other implementations the lengthof the one or more radial protrusions 295 is selected to be shorter sothat rotational movement of the spring clip 220 on the elongate memberis permitted upon the needle guard achieving the activated state, withrotational movement otherwise inhibited when the needle guard is in theready state or transitioning from the ready state to the activatedstate.

FIGS. 56A and 56B illustrate another key form with FIG. 56A depicting anelongate member with a flat side 296 and FIG. 56B depicting the base 118of the spring clip 220 with an aperture 119 that conforms with thecross-sectional shape of the elongate member.

As discussed above, according to some implementations a deformation ofat least a portion of the base 118 of spring clip 220 occurs when actedupon by the distal section of the elongate member to cause a diametricexpansion of aperture 119. In other implementations, as shown in FIG.57A, the base 118 comprises a plurality of deformable projections 298along the perimeter of opening 119. The material and dimensionalcharacteristics of the projections 298 are selected so that a bendingand/or compression of the projections results when a selected portion ofthe proximal section of the elongate member acts upon them as theelongate member is proximally pulled upon. For example, in theimplementation of FIG. 49, the base 118 of FIG. 57A may be used toachieve similar results. As a starting point the projections 298 aredimensioned so that a circle that connects their apices has a diameterthat permits the base 118 to slide along the proximal section 272 of theelongate member 270 until the base encounters the proximal end 275 offrustoconical segment 274. Preferably, but not necessarily, three ormore projections 298 spaced equidistant about the perimeter of aperture119 are provided to assist in maintaining an orthogonal relationshipbetween the base 118 and the longitudinal axis of the elongate member270 during the assembly of the device and also during its use. In otherwords, axial alignment of the base with respect to the elongate memberis better maintained. During activation the proximal force M applied tothe needle hub 704 causes the base 118 of the spring clip 220 to beurged distally on the frustoconical segment 274. The force appliedcauses the deformable projections 298 to deform (i.e., by compressionand/or bending) to permit the base 118 to travel along the outer surfaceof the frustoconical segment 274 until it reaches its distal end 276where it is stopped. The needle guard assembly otherwise activates in amanner similar to that described above in conjunction with FIGS.49A-49D.

In other implementations the ability of the aperture 119 to expand, andin some instances to contract, is achieved by the inclusion of one ormore slits 299 cut into the base 118 as shown in FIG. 57B. In additionto their suitability for use in the, for example, the implementation ofFIGS. 49A-49D, the base 118/aperture 119 constructions of FIGS. 57A and57B are particularly useful in conjunction with the elongate membersdepicted in FIGS. 46-48 by virtue of the aperture's 119 ability to adaptto diametric variations either by expansion and/or contraction.

FIGS. 58A-58C illustrate an elongate member 301 according to anotherimplementation. For the sake of simplicity, the figures show theelongate member 301 without the spring clip. FIG. 58A is an isometricview of the elongate member 301 alone. FIGS. 58B shows the elongatemember 301 mounted on a needle shaft 131 in a ready position. FIG. 58Bshows the elongate member 301 on the needle shaft 131 after the needleguard assembly has been activated with the distal tip 134 of the needle130 residing entirely within the elongate member 301. A distinguishingfeature of the elongate member 301 among those previously disclosedherein is the inclusion of a seal member 302 disposed at or near itsdistal end. The seal member 302 advantageously seals the distal tip 134of the needle 130 within the elongate member 301 after the distal tiphas been fully withdrawn into the elongate member. Such an arrangementfacilitates the containment of bodily fluids that may flow from theneedle tip 134 after its introduction within the elongate member 301.

The seal member 302 may comprise any of a variety of forms. In oneimplementation the seal member 302 comprises an elastomeric insert 303disposed within the distal end of the elongate member as shown in thefigures. In some implementations the elastomeric insert 303 has an outerdiameter greater than the inner diameter of the distal end of theelongate member 301. In such implementations the elastomeric insert 303is held within the elongate member 301 by compressive forces exerted bythe elastomeric insert against the inner wall of the elongate member. Inother implementations adhesive or heat bonding is used in lieu of or inconjunction with the aforementioned attachment method. In otherimplementations the seal member 302 comprises an elastomeric cap 305that stretches over and resides on the outside of the elongate member301 as shown in FIG. 59. In some implementations adhesive or heatbonding is used in lieu of or in conjunction with the aforementionedstretch attachment method.

In the implementations of FIGS. 58 and 59 a slit 304 that diametricallytransverses the face of the seal member 302 facilitates a passage of theneedle 130 through the seal member. Features other than a self-closingslit are also contemplated. As illustrated in FIGS. 58B and 58C, whenthe distal tip 134 of needle 130 assumes a position within the elongatemember 301 the slit 304 closes. In some implementations the distal endof the elongate member 301 comprises an enlarged distal end section 306for receiving or otherwise facilitating an attachment of the seal member302 to the elongate member as shown in FIGS. 58 and 59. In theimplementation of FIG. 59 the enlarged distal end section 306 provides aproximal annular shoulder 307 upon which the proximal portion of theelastomeric cap 302 may rest. An enveloping of the elastomeric cap 305over the distal end section 306 provides enhanced securement of theelastomeric cap on the elongate member.

In the preceding description of FIGS. 42-59 needle guard assembliescomprising a spring clip portion and an elongate member portion havebeen described within the confines of intravenous catheters. It isappreciated, however, that the needle guard assemblies of FIGS. 42-59may be integrated with a host of other types of needle productsincluding, but not limited to, syringes, guidewire introducers, bloodcollection devices, etc. In some instances what will distinguish theseother types of needle products from intravenous catheters and each otheris the manner in which the needle guard assembly is advanced over theneedle shaft. For example, in some instances mechanical propulsion toadvance the guard assembly along the needle shaft is provided directlyby a user's hand, a spring, pressurized air or other propulsion means.In the preceding description of FIGS. 42-59 the spring clips have beendisclosed as comprising first and second resilient arms 101 and 102. Itis important to note, however, that any of a variety of clipconfigurations is possible, such as, for example, single arm clips likethose shown in FIGS. 18, 19 and 24. Moreover, as with the implementationof FIGS. 60A and 60B below, the arm of the clip may rely on other means,other than its own resiliency, to close itself over the distal end ofthe elongate member. It is also important to note that many of thefeatures associated with the spring clips and elongate members disclosedherein (above and below) are interchangeable and/or combinable toformulate a wide variety of needle guard assemblies and safety needleproducts.

FIGS. 60A-60C illustrate a guidewire introducer 360 according to anotherimplementation. The guidewire introducer 360 comprises a needle 361whose proximal end is secured within a needle hub 364. The needlecomprises a change in profile 362 on its distal end near the needle'sdistal tip 363. When in a ready position a needle guard assembly resideswithin a housing 367 that is attached at its proximal end to the needlehub 364. The needle guard assembly comprises a first part 370 and asecond part 380. The first part 370 comprises a midsection that onlypartially circumscribes the shaft of the needle 361. Residing within themidsection is the second part 380 which is in the form of a cylindricalelongate member that fully surrounds the needle shaft. In oneimplementation, the proximal end of the elongate member 380 includes araised annular ring 381 that fits within an annular recess 373 in thebase of the first part 370 to secure the elongate member 380 to thefirst part 370. In one implementation the first part 370 comprises amolded plastic structure having an arm 371 that extends distally from abase where it is hinged. The arm 371 has a distal section 372 that isconfigured to rest against the shaft of the needle 361 when the guardassembly is in a ready position (see FIG. 60A) and to cover the distalend of the elongate member 380 when the guard assembly has beenactivated (see FIG. 60B). When in the ready position, the guard assembly370 is held within the housing 367 by retaining means (not shown in thefigures) against a force exerted by a coil spring 374, or otherresilient structure, that is situated to propel the guard distally whenit is released from the retaining means. In the example of FIGS. 60A and60B, the proximal end of the spring 374 is attached to the base of thehousing 367 and at least a portion of its distal end circumvents aportion of the molded plastic structure 370, including at least aportion of the arm 371. In use, when the needle guard is released fromthe retaining means, the compressed spring 374 expands distally topropel the needle guard forward until the distal tip 363 of the needle361 resides entirely within the elongate member 380. In addition topropelling the needle guard forward along the needle 361, the spring 374also compressively acts on the arm 371 to urge the arm 371 radiallyinward so that the distal section 372 of the arm covers the distal endof the elongate member 380.

In other implementations, the first part 370 and the second part 380 ofthe needle guard comprise spring clips and elongate members similar toor the same as those disclosed above and below. In such otherimplementations the spring 374 may be positioned beneath the base 118 ofthe spring clip so as to be situated to propel the spring clip distallyalong the needle shaft.

FIGS. 62A-62D illustrate a needle guard assembly similar to, forexample, those depicted in FIGS. 6-10, 20-23 and 26-29. FIGS. 62A and62B are top and side views of the needle guard, respectively, prior to afolding of the resilient arms 422 and 423 to form the spring clip 421.In FIGS. 62A and 62B the elongate member 430 is shown extending upwardlyfrom the base 118. As described above, the elongate member 430 maycomprise a part separate to the first part 420 whereby it is attached tothe base 118 or simply rides between the base 118 and the distal end ofthe resilient arms 422, 423. The elongate member 430 may also be formedfrom the first part 420 by means of a drawing process as previouslydescribed. As with the guidewire introducer 360 disclosed above, in someinstances it is desirable that the needle guard be propelled distallyalong the shaft of the needle in order for it to assume its activeposition. In the implementations depicted in FIGS. 60A-60C a coil spring374, separate to the clip itself, provides such propulsion. In theneedle guard assemblies of FIGS. 62A-62D, a spring means is not formedseparately from the clip but is instead formed from the same stockmaterial as the clip itself. That is, it is formed integrally with theclip. As shown in FIGS. 62A and 62B, an elongate protrusion 440 extendsfrom a side of the base 118 and is provided with a plurality oflongitudinally aligned elongate apertures 441. Like resilient arms 422and 423, the protrusion 440 also comprises a resiliency that results inthe formation of a spring 442 when the protrusion 440 is folded alonglines 443 as shown in FIGS. 62C and 62D. An aperture 446 in a base 445of the protrusion 440 is aligned with apertures 441 so that when theprotrusion is folded the needle guard assembly may be loaded onto theneedle shaft. In, for example, a guidewire introducer product like thatdepicted in FIGS. 60, the base 445 of the protrusion 440 may be attachedto the base of housing 367. When the needle guard is in the readyposition the formed spring 442 assumes a compressed state within thehousing 367 and acts upon the base 118 to urge the needle guardcomprising spring clip 421 and elongate member 430 distally along theneedle shaft toward the distal end of the needle. Upon the needle guardbeing released from the housing 367, spring 442 pushes the guarddistally until the distal tip of the needle resides entirely within theelongate member 430 as shown in FIGS. 62C and 62D.

In other implementations the elongate protrusion 440 simply acts as atether to limit distal advancement of the needle guard on the needleshaft. While in other implementations the protrusion is used to form thespring 442 and to also act as a limiting means to limit distaladvancement of the needle guard on the needle shaft.

FIGS. 63A-63D illustrate a needle guard 510 according to anotherimplementation. The needle guard may be manufactured from asubstantially flat material having resilient characteristics and with aconstruction that resembles or is the same as those shown in FIGS. 6A,6B, 20, 26 and 32. For descriptive purposes, like parts in FIGS. 63A-62Dutilize the same reference numerals as those used in FIG. 6A. It isimportant to note, however, that the construction is not in any waylimited to those illustrated in FIGS. 6A, 6B, 20, 26, 32 and 42.

As shown in FIG. 63A, in the as-cut or stamped configuration, the needleguard is equipped with first and second elongate biasing members 513 and514, respectively. In one implementation the first and second elongatebiasing members 513 and 514 are generally situated opposite andsubstantially parallel to the first and second resilient arms 101 and102, respectively. At least a distal end 515 of the first biasing member513 is longitudinally aligned with at least a portion of the secondresilient arm 102 so that when the needle guard 510 is formed andpositioned on the needle 130, the distal end 515 abuts a part of thesecond resilient arm 102 (see FIG. 63B) to impart a biasing force thatassists (along with the biasing force inherent to the second resilientarm 102) in urging the second resilient arm 102 against the shaft 131 ofneedle 130. In a like manner at least a portion of the distal end 516 ofthe second elongate biasing member 514 is longitudinally aligned with atleast a portion of the first resilient arm 101 so that when the needleguard 510 is formed and positioned on the needle 130, the distal end 516abuts a part of the first resilient arm 101 (see FIG. 63B) to impart abiasing force that assists (along with the biasing force inherent to thefirst resilient arm 101) in urging the second resilient arm 101 againstthe shaft 131 of needle 130.

Whereas FIG. 63B and 63C show the needle guard in a ready position priorto being activated to cover the distal tip 134 of the needle 130, FIG.63D shows the needle guard in an activated state where it is stopped ona change in profile 132 on the needle shaft 131 and the distal ends 107,108 of resilient arms 101, 102 are positioned over the distal tip 134.As shown in FIG. 63D, the distal ends 515, 516 of biasing members 513,514 continue to engage the arms 101, 102 when the needle guard is in theactivated state. Such engagement advantageously assists in maintainingthe arms 101,102 in their active positions and to resist outward forcesthat may be applied to the arms 101, 102 once the tip 134 has beingproperly covered.

Stop and/or engagement features may be incorporated on or within thearms 101, 102 and/or biasing members 513, 514 to assist in maintainingthe biasing members 513, 514 on the arms 101, 102 when the needle guardassumes its activated state. FIGS. 64-68 illustrate examples of suchfeatures. In some implementations, not shown in the figures, the distalends 515, 516 of biasing members 513, 514 are guided on the arms 101,102 by rails situated along at least a portion of the length of thearms. In the implementation of FIG. 64 cut-outs/notches 531 and 532 areprovided on the inner perimeter of arms 101 and 102, respectively. Inuse, at least when the needle guard 530 is in the activated state, asshown in FIG. 64B, at least a portion of the distal ends 515 and 516 ofthe biasing members reside in notches 532 and 531, respectively, toassist in maintaining the arms 101 and 102 in a position to cover thedistal tip 134 of the needle 130. In one implementation, as shown inFIG. 64C (a cross-sectional view along line A-A) an inner edge of arms101 and/or 102 are bent to form strong backs 533 to provide the armswith additional stiffness. In the implementation of FIG. 65,ledges/shoulders 534 and 535 are respectively formed on an inner edge ofarms 101 and 102 to which at least a portion of the distal ends 516 and515 of biasing members 514 and 513 abut when the needle guard 540 is inan activated state. In one implementation, at least the distal ends 515and 516 of biasing members 513 and 514 have a width dimension W1 that isgreater than the width dimension W2 of arms 101 and 102. In theimplementation of FIGS. 66A-66C each of arms 101 and 102 has along atleast a portion of their length a pair of stamped indentations 551 a,551 b that are longitudinally arranged so that a recess 552 existbetween them. As shown in FIG. 66C, at least a portion of the distalends 515, 516 of biasing members 513, 514 reside within a recess 552 atleast when the needle guard is in the activated state. In theimplementation of FIGS. 67A and 67B a raised feature 555 located on theouter side of each of arms 101 and 102 provides a surface on which atleast a portion of the distal ends 515, 516 of biasing members 513, 514rest when the needle guard is in the activated state as shown in FIG.67B. In the implementation of FIGS. 68A and 68B each of arms 101, 102are provided with apertures 556 that are adapted to receive tabs 557formed on the distal ends 515, 516 of biasing members 513, 514. As shownin FIG. 68B, the tabs 557 reside within the apertures 556 at least whenthe needle guard is in the activated state.

FIGS. 69A-69C show a needle guard similar to the needle guard depictedin FIGS. 67A and 67B. A difference lies in the construction of thedistal end of biasing member 514. As shown in FIGS. 69A and 69B, aprotrusion or tab 518 extends radially inward from the distal end 516and is configured to at least partially cover the bevel 136 of theneedle 130 when the needle guard assumes an activated state as shown inFIGS. 69B and 69C.

Like the implementation of FIG. 24, a needle guard incorporating thefeature of a biasing member may also comprise only one arm 101 that isadapted to cover the distal tip of the needle. As shown in FIGS. 70A and70B, in such an implementation arm 102 terminates at segment 560 and theguard is devoid of biasing member 513 Like the precedingimplementations, biasing member 514 is provided to act upon an outersurface of arm 101.

Biasing members may also be incorporated into needle guards comprisingelongate members as shown in FIG. 71. The example of FIG. 71 shows aversion of the needle guard 400 of FIG. 30 with biasing members 513 and514.

Numerous exemplary implementations have been disclosed and describedherein. It is to be appreciated however, that the present invention isin no way to be construed as to being limited to these examples.

What is claimed is:
 1. A guidewire introducer comprising: a needlehaving a needle shaft and a distal tip, the needle shaft having a changein profile near the distal tip; a needle guard transitional between aready position where the distal tip of the needle is in an unprotectedstate and an activated position where the distal tip of the needle is ina protected state, the needle guard comprising an arm that extendsdistally from a base having an aperture formed therein, the needle guardslideably mounted on the needle shaft with the needle shaft passingthrough the aperture formed in the base, the needle guard furthercomprising an elongate member extending distally from a position at ornear the base and slideable along the needle shaft as the needle guardis moved between the ready position and the activated position, theelongate member having a proximal end, a distal end and a throughpassage extending therebetween, a first portion of the through passagelocated at or near the proximal end of the elongate member is sized toengage with the change in profile of the needle shaft to limit distalmovement of the needle guard on the needle shaft, the elongate memberhaving a length such that when the change in profile engages the firstportion of the through passage the entirety of the distal tip of theneedle is positioned to reside within the through passage of theelongate member, when the needle guard is in the ready position a distalsection of the arm is urged against an outer side of the needle shaft,the needle guard is configured such that as it transitions from theready position to the activated position, the distal section of the armmoves distally along the outer side of the needle shaft until it movesradially inward upon the needle guard assuming the activated position toat least partially cover the distal end of the elongate member, theelongate member being sufficiently rigid to restrict longitudinalmovement of the needle with respect to the needle guard when the distalsection of the arm at least partially covers the distal end of theelongate member.
 2. A guidewire introducer according to claim 1, whereina proximal end of the needle extends through and is coupled with aneedle hub, the guidewire introducer further comprising a housing havinga proximal end and an open distal end, the proximal end of the housingcoupled to the needle hub, when in the ready position the needle guardresides within the housing, when in the activated position the needleguard resides outside the housing.
 3. A guidewire introducer accordingto claim 2, further comprising a resilient member situated in a proximalsection of the housing, the resilient member having a proximal end and adistal end, when the needle guard is in the ready position the resilientmember is in a compressed state and arranged to act on the needle guardto urge the needle guard towards the distal end of the needle.
 4. Aguidewire introducer according to claim 3, wherein the needle guard isheld in the ready position within the housing by a retaining elementthat is moveable between a first position and a second position, whenthe retaining element is in the first position the retaining elementengages the needle guard to hold the needle guard in the ready position,when the retaining element is in the second position the retainingelement is in disengagement with the needle guard to permit the needleguard to be propelled by the resilient member toward the distal end ofthe needle so as to assume the activated position.
 5. A guidewireintroducer according to claim 1, wherein the distal end of the elongatemember comprises a conformable material.
 6. A guidewire introduceraccording to claim 1, wherein the distal section of the arm comprises aconformable material.
 7. A guidewire introducer according to claim 1,wherein each of the distal section of the arm and the distal end of theelongate member comprises a conformable material.
 8. A guidewireintroducer according to claim 1, wherein the elongate member comprises areservoir at or near its distal end for collecting blood or bodilyfluids that may emanate from the distal tip of the needle when theneedle guard is in the activated position.
 9. A guidewire introduceraccording to claim 1, wherein the elongate member comprises an enlargeddiameter distal portion that defines a cavity located at the distal endof the elongate member, a bushing being retained within the cavity andsituated to concentrically locate the needle within the elongate memberand to wipe blood or bodily fluids from an exterior surface of theneedle when the needle moves axially through the elongate member.
 10. Aguidewire introducer comprising: a needle having a needle shaft and adistal tip, the needle shaft having a change in profile near the distaltip; a needle guard transitional between a ready position where thedistal tip of the needle is in an unprotected state and an activatedposition where the distal tip of the needle is in a protected state, theneedle guard comprising an arm that extends distally from a base havingan aperture formed therein, the needle guard slideably mounted on theneedle shaft with the needle shaft passing through the aperture formedin the base, the aperture sized to engage with the change in profile ofthe needle shaft to limit the distal movement of the needle guard on theneedle shaft, the needle guard further comprising an elongate memberextending distally from a position at or near the base and slideablealong the needle shaft as the needle guard is moved between the readyposition and the activated position, the elongate member having aproximal end, a distal end and a through passage extending therebetween,the elongate member having a length such that when the change in profileengages the aperture in the base, the entirety of the distal tip of theneedle is positioned to reside within the through passage of theelongate member, when the needle guard is in the ready position a distalsection of the arm is urged against an outer side of the needle shaft,the needle guard is configured such that as it transitions from theready position to the activated position the distal section of the armmoves distally along the outer side of the needle shaft until it movesradially inward upon the needle guard assuming the activated position toat least partially cover the distal end of the elongate member, theelongate member being sufficiently rigid to restrict longitudinalmovement of the needle with respect to the needle guard when the distalsection of the arm at least partially covers the distal end of theelongate member.
 11. A guidewire introducer according to claim 10,wherein a proximal end of the needle extends through and is coupled witha needle hub, the guidewire introducer further comprising a housinghaving a proximal end and an open distal end, the proximal end of thehousing coupled to the needle hub, when in the ready position the needleguard resides within the housing, when in the activated position theneedle guard resides outside the housing.
 12. A guidewire introduceraccording to claim 11, further comprising a resilient member situated ina proximal section of the housing, the resilient member having aproximal end and a distal end, when the needle guard is in the readyposition the resilient member is in a compressed state and arranged toact on the needle guard to urge the needle guard towards the distal endof the needle.
 13. A guidewire introducer according to claim 12, whereinthe needle guard is held in the ready position within the housing by aretaining element that is moveable between a first position and a secondposition, when the retaining element is in the first position theretaining element engages the needle guard to hold the needle guard inthe ready position, when the retaining element is in the second positionthe retaining element is in disengagement with the needle guard topermit the needle guard to be propelled by the resilient member towardthe distal end of the needle so as to assume the activated position. 14.A guidewire introducer according to claim 10, wherein the distal end ofthe elongate member comprises a conformable material.
 15. A guidewireintroducer according to claim 10, wherein the distal section of the armcomprises a conformable material.
 16. A guidewire introducer accordingto claim 10, wherein each of the distal section of the arm and thedistal end of the elongate member comprises a conformable material. 17.A guidewire introducer according to claim 10, wherein the elongatemember comprises a reservoir at or near its distal end for collectingblood or bodily fluids that may emanate from the distal tip of theneedle when the needle guard is in the activated position.
 18. Aguidewire introducer according to claim 10, wherein the elongate membercomprises an enlarged diameter distal portion that defines a cavitylocated at the distal end of the elongate member, a bushing beingretained within the cavity and situated to concentrically locate theneedle within the elongate member and to wipe blood or bodily fluidsfrom an exterior surface of the needle when the needle moves axiallythrough the elongate member.